BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    POWER TEK II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPL-50 SPIROLYSER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XIA LP POLYAXIAL SCREW 6.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    XIA ROD DIA. 6 X 480

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    XIA LP POLYAXIAL SCREW 5.5 X 45MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016

    XIA POLYAXIAL SCREW 8.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MJK·March 26, 2013

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 8, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·June 12, 2008

    BD SYRINGE 20ML LL TIP CONV PAK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·August 29, 2019

    XIA LP POLYAXIAL SCREW 6.5 X 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-VS·Product code NTE·December 16, 2010

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022